The goal of this clinical trial is to test the safety and immunogenicity of PHV02 live, attenuated recombinant vesicular stomatitis virus vaccine expressing the Nipah Virus glycoprotein in healthy adult subjects. The main questions it aims to answer are: * which doses of PHV02 are safe to administer to and well-tolerated by healthy adult subjects as a 2 dose regimen given 1 month apart? * what is the immunologic response (Nipah-specific IgG ELISA antibody and neutralizing antibodies) to each dose level after a 2-dose regimen given 1 month apart? Participants will receive 2 intramuscular injections of PHV02 (2x105, 2x106, and 2x107 plaque-forming units \[pfu\]) or placebo on Day 1 and Day 29 and will be followed for 197 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
120
Nipah virus vaccine
Placebo
Cenexel ACT (Anaheim Clinical Trials)
Anaheim, California, United States
Cenexel RCA (Research Centers of America)
Hollywood, Florida, United States
Cenexel JBR (JBR Clinical Research)
Salt Lake City, Utah, United States
Percentage of participants with local injection site and systemic adverse events (AEs)
Time frame: 14 days after each dose
Percentage of participants with joint related symptoms, rash and unsolicited AEs
Time frame: 28 days after each dose
Percentage of participants with neurologic AEs
Time frame: Study Days 1-57
Percentage of participants with medically-attended AEs (MAAEs) and serious AEs (SAEs)
Time frame: From time of injection through final study visit (Day 197)
Proportion of participants with recombinant vesicular stomatitis virus (rVSV) RNA (Cohort 1 only) in plasma, urine and saliva
Time frame: From time of injection through Day 43
Proportion of participants who seroconvert compared to Day 1
Time frame: Day 29 and Day 57
Geometric mean titers of IgG and ELISA neutralizing antibodies
Time frame: Day 1, 29, 57
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